HbA1c (glycated hemoglobin)
Metabolic· appears in 400+ cited findings in this library
What it is and how the reviews use it
HbA1c (glycated hemoglobin) is a measure used in regulatory review documents, often as an endpoint in clinical trials for diabetes treatments. It reflects average blood glucose levels over the past two to three months. The FDA review for Ozempic defines an HbA1c reduction from baseline (comparator-adjusted range) as -0.3% to -1.2%. Inclusion criteria for trials often specify an HbA1c range, such as 7.5-9.5% for Ozempic trials or ≥6.5% and ≤10.5% for Synjardy trials.
Regulatory reviews frequently report HbA1c changes from baseline or the percentage of patients achieving specific HbA1c targets. For instance, the Rybelsus FDA Review noted an HbA1c change from baseline of -1.23%. The Jardiance FDA Review reported an HbA1c reduction from baseline of -0.72%. In the Mounjaro FDA Review, the HbA1c change from baseline at Week 52 for placebo (GPGI) was -0.88%.
Real examples — cited to the source page
| NOVO — Rybelsus | HbA1c change from baseline | -1.23 | Rybelsus FDA Review, p.22 |
| Boehringer Ingelheim — Jardiance | HbA1c reduction from baseline | -0.72 | Jardiance FDA Review, p.92 |
| Eli Lilly and Company — Mounjaro | HbA1c change from baseline at Week 52 for placebo (GPGI) | -0.88 | Mounjaro FDA Review, p.96 |
| NOVO — Ozempic | Patients reaching HbA1c <6.5% | 17.2 | Ozempic FDA Review, p.62 |
| ELI LILLY AND CO — Zepbound | Difference in HbA1c change from placebo | -0.4 | Zepbound (Autoinjector) FDA Review, p.33 |
| Novo Nordisk A S — Tresiba | Upper HbA1c limit for trials where OADs were discontinued at randomisation | 10 | Tresiba EMA EPAR public assessment report, p.42 |
| ASTRAZENECA AB — Farxiga | Mean baseline HbA1c | 8.3 | Farxiga FDA Review, p.15 |
| Boehringer Ingelheim — Synjardy | Non-inferiority margin for HbA1c in Study 1276.10 | 0.35 | Synjardy FDA Review, p.32 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Every HbA1c finding in the library — searchable and answerable in plain language — is in the Metabolic research library →
Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.